NCT00452920撤回1 期
A Phase I/II Study of Docetaxel as a Radiosensitizer for Locally Advanced Cervical Cancer (GIA 13026)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Recommended phase II dose (Phase I)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with radiation therapy and to see how well they work in treating patients with stage II, stage III, or stage IV cervical cancer.
详细描述
OBJECTIVES:
Primary
- Determine the recommended phase II dose (RPTD) of docetaxel when administered with radiotherapy in patients with stage IIB-IVA cervical cancer. (Phase I)
- Assess the progression-free survival of patients treated with this regimen. (Phase II)
Secondary
- Determine the safety, feasibility, and toxicity of this regimen in these patients. (Phase I)
- Assess the toxicity of this regimen at the RPTD in these patients. (Phase II)
- Determine the response in patients treated with this regimen. (Phase II)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed squamous cell carcinoma of the uterine cervix
- •Locally advanced (stage IIB- IVA) disease
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 8.0 g/dL
- •WBC ≥ 3,000/mm^3
- •Creatinine normal
- •Bilirubin normal
- •SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase (AP) ≤ ULN OR AP ≤ 4 times ULN if SGOT and SGPT ≤ ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for up to 6 months after completion of study treatment
- •No history of severe allergic reactions to agents containing polysorbate 80
- •No concurrent uncontrolled illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness or social situations that would preclude compliance with study requirements
- •No peripheral neuropathy ≥ grade 2
- •No HIV positivity
- •PRIOR CONCURRENT THERAPY:
- •More than 4 weeks since prior unrelated therapy and recovered
- •No prior chemotherapy or pelvic radiotherapy
- •No other concurrent investigational agents or anticancer agents or therapies
排除标准
- 未提供
结局指标
主要结局
Recommended phase II dose (Phase I)
Progression-free survival (Phase II)
次要结局
- Toxicity (Phase II)
- Response (Phase II)
研究者
研究点 (1)
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